Foot Bath on Fever Management in Children (EWWFBFMC) (EWWFBFMC)

Effect of Warm Water Foot Bath on Fever Management in Children: A Randomized Controlled Trial

Reducing the dependency on medication in lowering fever, which is one of the most common symptoms in childhood, and developing safer and more feasible alternative methods are important for child health. This study aims to evaluate the effect of warm water foot baths on vital signs and pain in children, and to scientifically investigate this effect through a randomized controlled trial.

Study Overview

• Status: Completed
• Conditions: Nursing Caries
• Intervention / Treatment: Other: Application Footbath

Detailed Description

Fever is one of the most common symptoms in childhood, especially in children under the age of five. While it is the most frequent reason for visits to healthcare institutions, it accounts for 25% of pediatric emergency visits. Lack of knowledge about fever in parents triggers fear, and the thought that it can cause seizures, disability, and brain damage induces anxiety and panic in many families. In the presence of anxiety and panic, families may quickly resort to early and incorrect treatment. Administering less medication than necessary for low fevers or high doses for high fevers, repeated use of antipyretics, and inappropriate use of antibiotics lead to ineffective management, resulting in an increase in repeated emergency visits and unnecessary crowding in emergency services. Published guidelines on high fever have emphasized focusing on pain and comfort rather than reducing fever in children. It is reported that foot baths, preferred in pain management, effectively reduce pain and increase comfort. Additionally, guidelines related to fever highlight that warm applications after medication administration can effectively lower persistent fever. Warm water foot bath therapy dilates blood vessels, increases blood circulation, releases heat as sweat, and supports increased oxygenation. Increased circulation improves tissue nutrition and reduces stress. Literature has shown that body temperature decreased in children who received a warm water foot bath. Similarly, studies reported that warm water foot baths were effective in reducing fever in individuals with complaints of high fever.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Kağıthane, Istanbul, Turkey (Türkiye), 34098
      • Atlas University
    • Kâğıthane, Istanbul, Turkey (Türkiye), 34098
      • Atlas University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The child is between 1-5 years old. The child has presented to the emergency department with a fever of 38.3°C or higher.
• The child is a patient with "Green Area" (specific condition or disease). The child has no chronic illness. The child has not used any other antipyretic medication in the last 6 hours.
• The child has been administered 15 mg/kg of oral paracetamol as prescribed by the doctor.
• The child and their parent(s) have volunteered to participate in the study. Written consent from the parent(s) is obtained.

Exclusion Criteria:

• Individuals who have not agreed to participate voluntarily in the study.
• Children who have been unable to take paracetamol due to spillage or vomiting.
• Children with compromised skin integrity.
• Individuals who have undergone surgical procedures that would hinder the child's activity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Application Footbath; The experimental group will then receive the first foot bath with water at 38-40°C for approximately 10 minutes. After this, the second set of physiological parameters will be measured at the 40th minute. The child will rest for 10 minutes, followed by measurement and recording of the third set of parameters at the 50th minute. A second foot bath at 38-40°C will be applied for another 10 minutes. After this, the fourth set of physiological parameters will be measured, and the FLACC pain score (2nd measurement) will be recorded by the same nurse observer and parent at the 60th minute. The procedure will then be terminated.	Other: Application Footbath; The foot bath application for the experimental group will be applied with water at 38-40 degrees Celsius for an average of 10 minutes under thermometer control. Immediately afterward, the second physiological parameters will be measured.
No Intervention: Control Group; Approximately 10 minutes after the application of the antipyretic, the adaptation of the family and the child to the clinic will be awaited. Children and families who meet the sample selection criteria and verbally and in writing agree to participate in the study will be included. A data collection form will be applied to all members of the sample group, and the information will be recorded by the researcher on the form. (20th minute) The parents of the children and the observer nurse will be explained how to use the FLACC pain assessment scale. For inter-observer agreement, the nurse administering the antipyretic and the accompanying parent will simultaneously evaluate using the scale. Throughout the process, the parents of both groups will be with the child.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLACC SCORE	Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain	0 minute
FLACC SCORE	Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain	30 minute
FLACC SCORE	Pain Scale (Max 10 Points, Min. 0 Points) 0 points: No Pain. 10 Points: High Pain	50 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart Rate	0 minute
Heart Rate	Heart Rate	30 minute
Heart Rate	Heart Rate	40 minute
Heart Rate	Heart Rate	50 minute
Heart Rate	Heart Rate	60 minute

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiration Rate	Respiration Rates	0 minute
Respiration Rate	Respiration Rates	30 minute
Respiration Rate	Respiration Rates	40 minute
Respiration Rate	Respiration Rates	50 minute
Respiration Rate	Respiration Rates	60 minute
SpO2	Saturation Level	0 minute
SpO2	Saturation Level	30 minute
SpO2	Saturation Level	40 minute
SpO2	Saturation Level	50 minute
SpO2	Saturation Level	60 minute
Fever	Body Temparature	0 minute
Fever	Body Temparature	30 minute
Fever	Body Temparature	40 minute
Fever	Body Temparature	50 minute
Fever	Body Temparature	60 minute

Collaborators and Investigators

• Sponsor: Atlas University
• Collaborators: Koç University
• Investigators: Principal Investigator: semin dinç, Atlas University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: E-2268639050.99-46589

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No